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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01975701




Registration number
NCT01975701
Ethics application status
Date submitted
28/10/2013
Date registered
5/11/2013

Titles & IDs
Public title
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Scientific title
A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
Secondary ID [1] 0 0
CBGJ398X2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma or Other Glioma Subtypes 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGJ398

Experimental: BGJ398X - To estimate anti-tumor efficacy of BGJ398


Treatment: Drugs: BGJ398
Capsule for oral use.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Safety and Tolerability
Timepoint [3] 0 0
5 years

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
2. Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1, FGFR2,or FGFR3
3. RANO defined tumor progression by MRI in comparison to a prior scan
4. Patients must have received prior external beam radiotherapy and temozolomide.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. History of another primary malignancy
2. Prior or current treatment with a FGFR inhibitor
3. Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2018
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Netherlands
State/province [8] 0 0
The Netherlands
Country [9] 0 0
Spain
State/province [9] 0 0
Catalunya
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Switzerland
State/province [11] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01975701